VIVUS submits a NDA to the FDA for obesity drug Qnexa

Dec 30 2009

VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two pivotal, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors.

"This NDA filing is a major milestone for VIVUS and the Qnexa program. The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, chief executive officer for VIVUS. "The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries. I wish to thank all of the VIVUS employees, contractors and advisors who contributed to the program and made this on-time filing possible."

Previously reported highlights from the two 56-week EQUIP and CONQUER studies comprising more than 3,750 patients include:

• Weight loss of up to 14.7% (37 lbs) achieved by patients treated with Qnexa for 56 weeks in the EQUIP study;

• Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;

• FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;

• Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and

• Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.